Drug · Small Molecule

Lurbinectedin

CI-DRUG-00000749Explore in graph →CHEMBL4297516 Approved

Regulatory

Approvals (6)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

health-canada-dpdRegulatory6 approval records from 3 sources (hover a row badge for its dataset) · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
CA Health Canada	—	Marketed in Canada as ZEPZELCA (DIN 02520834) under ATC L01XX69 LURBINECTEDIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Dormantsince Jun 17, 2026	Dec 6, 2021	health-canada-dpd
EU EMA	Lung Small Cell Carcinoma	Zepzelca, in combination with atezolizumab, is indicated for the maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide.	approved	May 29, 2026	ema
US FDA	—	Efficacy supplement 2025-10-02 (see label)	approved	Oct 2, 2025	openfda
US

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 14 days agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 3	29	19	10	56	6	CA, EU, US	Jun 15, 2020	2009-03
Malignant Lung Neoplasm	Approved	Phase 3	20	13	8	27	3	EU, US	Jun 15, 2020	Sep 11, 2013
Malignant Ovarian Neoplasm	Phase3	Phase 3	1	1	1	2	0	—	—	2015-05
Malignant Breast Neoplasm	Phase2	Phase 2	0	0	0	2	0

Curated evidence

Clinical evidence (0)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

Data not yet available

No curated evidence item mentions this therapy yet.

Clinical trials

Trials with this intervention (59)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–50 of 59 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT07155174	A Study to Evaluate the Optimal Dose, Adverse Events and Change in Disease Activity of Intravenous ABBV-706 in Combination With Atezolizumab Versus Standard of Care as First-Line Treatment in Adult Participants With Previously Untreated Extensive Stage Small Cell Lung Cancer(SEZanne)	recruiting	Phase 2	180	AbbVieINDUSTRY	13	Sep 23, 2026	clinicaltrials
NCT07365241	A Study to Evaluate Adverse Events and Change in Disease Activity of Intravenous ABBV-706 Versus Standard of Care in Adult Participants With Relapsed/Refractory Small Cell Lung Cancer

Molecule

Record

Kind: Small Molecule
Mechanism: DNA negative modulator
UNII: 2CN60TN6ZS
Aliases: Lurbinectedin, Lurbinectedina, Lurbinectedine, Pm01183, PM-01183, PM01183, PM-1183, PM1183, Tryptamicidin, Zepsyre, ZEPZELCA

Data updated 2 days agoSource updated unknown

Identifiers

Codes (4)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01XX69	LURBINECTEDIN
DIN (Health Canada)	02520834	ZEPZELCA
DPD drug code	101003